PSDV has been alerted many times on the Matrix board on investorshub.com. PSDV is entitled to $25 million milestone payment from ALIM upon approval of its product Illuvien in October 2013. PSDV will also receive 20% of sales from ALIM. The product is already available in other countries therefore it seems the chances of good news in US is rather high. At the very least, we can likely ride the momo. Matrix has been adding on dips. Great stock to hold for a few months.
Click on the chart to see a larger version.
We can see a nice golden cross that has formed in the middle of march and the stocks been roaring since. Great to get in when price touches the 50ma line, classic bounce may likely occur.
Weekly chart shows increased volume recent months. More importantly, price has made it back above the 200ma. Psivida jumped 1.78% today with volume of 136,0835.
Positive news came out today premarket announcing 'yes' in regards to the use of ILUVIEN for some patients from National Institute of Health and Care Excellence. Nice Appraisal Committee making this recommendation confirms effectiveness of ILUVIEN.
8:20AM pSivida announces UK's NICE says yes to ILUVIEN in some patients with diabetic macular edema in new draft guidance (PSDV) 3.37 : Co announced that the United Kingdom's National Institute for Health and Care Excellence (NICE) issued draft guidance recommending ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema considered insufficiently responsive to available therapies. Following a rapid review by NICE, this recommendation proposes a change to the published guidance issued by NICE in Jan 2013 and takes into consideration a patient access scheme submitted by Alimera (ALIM). The NICE Appraisal Committee making the recommendation confirmed the conclusions that ILUVIEN is clinically effective in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies as well as in the subgroup of pseudophakic chronic DME patients. Based on the PAS, the Committee concluded that the cost-effectiveness threshold had been met for the subgroup of chronic DME patients who are pseudophakic. NICE will issue final guidance after a comment period.
Related Articles:
What Illuvien May Mean to Alimera And PSivida
pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy. ILUVIEN for DME has not been approved in the US. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's FDA-approved product, Retisert® for the treatment of posterior uveitis, is licensed to Bausch & Lomb.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: Alimera’s ability to finance, achieve additional marketing approvals, successfully complete pricing and reimbursement discussions for, commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; Alimera’s ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; financing and success of planned Phase III posterior uveitis trials, including efficacy, side effects and risk/benefit profile of the posterior uveitis micro-insert; initiation, financing and success of Latanoprost Product Phase II trials and exercise by Pfizer of its option; development of products using Tethadur and BioSilicon and potential collaborations for those products; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty revenues; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; possible influence by Pfizer; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Click on the chart to see a larger version.
We can see a nice golden cross that has formed in the middle of march and the stocks been roaring since. Great to get in when price touches the 50ma line, classic bounce may likely occur.
Weekly chart shows increased volume recent months. More importantly, price has made it back above the 200ma. Psivida jumped 1.78% today with volume of 136,0835.
Positive news came out today premarket announcing 'yes' in regards to the use of ILUVIEN for some patients from National Institute of Health and Care Excellence. Nice Appraisal Committee making this recommendation confirms effectiveness of ILUVIEN.
8:20AM pSivida announces UK's NICE says yes to ILUVIEN in some patients with diabetic macular edema in new draft guidance (PSDV) 3.37 : Co announced that the United Kingdom's National Institute for Health and Care Excellence (NICE) issued draft guidance recommending ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema considered insufficiently responsive to available therapies. Following a rapid review by NICE, this recommendation proposes a change to the published guidance issued by NICE in Jan 2013 and takes into consideration a patient access scheme submitted by Alimera (ALIM). The NICE Appraisal Committee making the recommendation confirmed the conclusions that ILUVIEN is clinically effective in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies as well as in the subgroup of pseudophakic chronic DME patients. Based on the PAS, the Committee concluded that the cost-effectiveness threshold had been met for the subgroup of chronic DME patients who are pseudophakic. NICE will issue final guidance after a comment period.
Related Articles:
What Illuvien May Mean to Alimera And PSivida
pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy. ILUVIEN for DME has not been approved in the US. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's FDA-approved product, Retisert® for the treatment of posterior uveitis, is licensed to Bausch & Lomb.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: Alimera’s ability to finance, achieve additional marketing approvals, successfully complete pricing and reimbursement discussions for, commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; Alimera’s ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; financing and success of planned Phase III posterior uveitis trials, including efficacy, side effects and risk/benefit profile of the posterior uveitis micro-insert; initiation, financing and success of Latanoprost Product Phase II trials and exercise by Pfizer of its option; development of products using Tethadur and BioSilicon and potential collaborations for those products; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty revenues; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; possible influence by Pfizer; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
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